CMS Coverage Decision of Pulmonary Embolectomy Criticized

JAMA Internal Medicine editor and a UCSF colleague wrote in a New England Journ of Medicine opinion piece that the decision highlights the need to establish a new requirement that would make coverage decisions contingent on evidence of benefit for Medicare population.

Last month, CMS loosened its coverage policy for catheter-based procedures that break up pulmonary embolisms, blood clots in the blood vessels of the lung that can result in serious lung damage and, in extreme cases, death.

But in an opinion piece in this week’s New England Journal of Medicine, two University of California, San Francisco, cardiologists argue that the CMS decision is a mistake and could led to Medicare beneficiaries undergoing a risky procedure with no proven clinical benefits.

Sanket S. Dhruva, M.D., M.H.S., and Rita F. Redberg, who is editor of JAMA Internal Medicine say the clinical trial results supporting the use of the procedures used surrogate endpoints, not outcomes such as better functional status, and that the volunteers for the trials were much younger than average Medicare beneficiary.

They also call for a fundamental change to CMS coverage decisions that would make coverage contingent upon evidence of benefit for the Medicare population.

Pulmonary embolisms are commonly treated with anticoagulants, such as heparin. But as described by Dhruva and Redberg, some patients get additional treatment that breaks up the embolism more directly. Catheter-based aspiration thrombectomy breaks up the embolism mechanically with devices on the tip of a catheter that has been threated the blood vessel.

According to Dhruva and Redberg, CMS has deemed catheter-based aspiration thrombectomy an experimental therapy for almost 40 years and therefore not eligible for coverage. In October, the agency lifted ended that noncoverage decision, but that doesn’t mean that Medicare will now start covering the procedure nationwide. Instead, say Dhruva and Redberg, it delegated the decision to Medicare administrative contractors, private insurers that process claims and make coverage decisions at the regional level. In Dhruva and Redberg’s view, having the Medicare administrative contractors make the coverage will introduce “unwarranted variation” into Medicare coverage: “Medicare beneficiaries in Florida aren’t more or less likely to benefit those in Alaska,” they wrote. They also say that CMS had a ready alternative: an approval category called “coverage with evidence development.” The federal agency could have made coverage contingent upon enrollment in a clinical trial.